Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

Not Applicable

Recruiting

• Conditions: Surgical Wound
• Interventions: Other: Photobiomodulation; Other: Protection with surgical dressing

• Registration Number: NCT06073678
• Lead Sponsor: University of Sao Paulo

Brief Summary

The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Palate with normal and healthy mucosa
• Patient with indication of gingival graft surgery

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Exclusion Criteria

• Patients using prosthesis with palate coverage
• Former removal of gingival graft in the palate
• Smokers
• Pregnancy and breastfeeding mothers
• Use of anticonvulsants and immunosuppressors

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation	Photobiomodulation	Red laser irradiation on palate wound at the day of the surgery and after 2, 4 and 6 days postoperatively. Protection of wound with surgical dressing during 7 days.
Control	Protection with surgical dressing	Protection of wound with surgical dressing during 7 days.

Primary Outcome Measures

Name	Time	Method
Somatosensory recovery	30 and 60 days postoperatively	Mechanical and pain detection threshold measured with Von Frey filaments

Secondary Outcome Measures

Name	Time	Method
Assessment of Pain	24 hours, 3 days, 7 days and 14 days	Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain.
Measurement of Quality of life	Baseline, 7 days and 14 days postoperatively	Patients fill the Oral Health Impact Profile (OHIP-14) questionnaire. It comprises 14 questions about oral health problems. In each question the patient may answer if they he have those problems very often (coded 4), fairly often (coded 3), occasionally (coded 2), hardly ever (coded 1) or never (coded 0). Questionnaire scale ranges from 0 to 56 with higher scores indicating poorer quality of life.

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, São Paulo, Brazil